A Miami Veterans Affairs (VA) clinical site is now part of Longeveron’s Phase 2a clinical trial testing Lomecel-B — an investigational, bone marrow-derived, medicinal signaling cell (MSC) treatment — in patients with mild Alzheimer’s disease. The new clinical site was added following a Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Veterans…
The therapeutic candidate allopregnanolone is safe and well-tolerated in people with early Alzheimer’s disease, according to data from a Phase 1b/2a clinical trial that also investigated the medication’s maximum-tolerated dose. Moreover, MRI scans showed that allopregnanolone — dubbed ALLO by researchers — may protect against brain tissue loss in these patients. “Allopregnanolone was well-tolerated and…
A Russian military plane crash near Tetiana Zamorska’s home in Kyiv, Ukraine, was a sign that it was time for her and her family to leave. The treacherous, 34-hour pilgrimage that ultimately brought the group of eight by car to temporary accommodations in neighboring Poland last month was physically and emotionally difficult, Zamorska recently told BioNews, Inc.,…
Biogen is continuing to actively recruit Alzheimer’s patients for its Phase 4 ICARE AD-US trial, which is evaluating the long-term safety and effectiveness of Aduhelm (aducanumab) in the real-world U.S. clinical setting. Participants — including a targeted enrollment of 16% Latino and African American patients — are currently being enrolled at more than 10 sites in…
A standardized MRI protocol to screen for brain imaging abnormalities in people with Alzheimer’s who are being treated with Aduhelm in a large observational study was described in a presentation at the 2022 American Academy of Neurology (AAN) annual meeting. “Consistency in MRI acquisition is important for efficient and treatment and to overcome [variation] in…
Biogen has withdrawn its application seeking approval of Aduhelm (aducanumab) to treat early Alzheimer’s disease in the European Union. A committee of the European Medicines Agency (EMA) recommended against approving Aduhelm late last year. Biogen had requested a re-examination of that decision, made by the Committee for Medicinal Products for Human Use (CHMP), but now the…
The European Commission is expected to propose a new governing framework for health data next month, called the European Health Data Space (EHDS), with the aim of connecting national health systems to facilitate secure and efficient transfer of data across systems in different European nations. The move is expected to help encourage evidence-based healthcare, spur…
A first patient has been dosed in a Phase 2 trial of XPro1595, INmune Bio’s candidate therapy for Alzheimer’s disease. The MINDFuL trial (NCT05318976) aims to recruit around 201 people, ages 60–85, with mild Alzheimer’s and biomarkers of brain inflammation across multiple sites in the U.S., Australia, and Canada. Top-line results are expected in 2023. For…
ABvac40, an investigational vaccine, was safe and led to antibodies forming against the toxic amyloid-beta 40 peptide in people with Alzheimer’s disease, according to data from a Phase 2 trial. ABvac40’s developer, Araclon Biotech, has also made progress in developing a blood test to detect Alzheimer’s in its early stages, Araclon’s lead shareholder, Grifols, reported…
Sciensus Rare, a Dutch healthcare group, was given rights to distribute CogniCann, MGC Pharmaceutical’s cannabinoid-based investigative treatment for people with dementia and Alzheimer’s disease in Europe, should it be approved for commercial use or use in select early access programs. The agreement stipulates that Sciensus Rare will have four years of exclusive distribution rights for CogniCann in…
